Independent Innovator and Repurposing Act Would Create New Patent Term Extension for Certain Biologics Patents

By Kurt R. Karst –      

Earlier this week, Senator Richard Blumenthal (D-CT) and Representatives Joaquin Castro Joaquin Castro (D-TX) and Randy Forbes (R-VA) introduced the “Independent Innovator and Repurposing Act” in their respective houses of Congress (S. 2150; H.R. 4287).  Styled as a bill “[t]o advance the public health by encouraging independent innovators to pursue drug repurposing research and develop new treatments and cures by providing appropriate intellectual property protections for those innovations,” the Independent Innovator and Repurposing Act, if enacted, would allow the sponsor of a BLA for a biological product approved pursuant to Section 351(a) of the Public Health Service Act (“PHS Act”) to obtain a Patent Term Extension (“PTE”) of 5 years (or an interim extension for successive 1-year periods as appropriate) for a patent claiming a method of using that approved biological product because of “regulatory delay.” 

The bill does not amend the PTE statute at 35 U.S.C. § 156.  Rather, the bill allows the owner of record of an applicable patent to submit to the Director of the Patent and Trademark Office (“PTO”) an application requesting the extension.  Such an application must contain: (1) the identify of the biological product; (2) information on the patent for which an extension is being sought (and the identity of each claim of such patent that claims the method of using the biological product); (3) a brief description of the activities undertaken by the patent owner (or the agent of such owner) during a specified regulatory review period period; and (4) information demonstrating that the patent was issued to an “independent innovator,” that the owner of record is the “independent innovator” or a “qualified small business” in which the “independent innovator” has an ownership interest, that a Section 351(a) BLA was submitted to FDA for the claimed method of use, and that a period of not less than 10 years elapsed between the original date of submission of an IND for investigating the patented method of use and the date on which FDA approved the Section 351(a) BLA.

An “independent innovator” is defined in the bill to mean: “any person or entity that (i) obtains a method of use patent for a biological product; and (ii) is not, at the time of invention or patent filing, affiliated with the holder of a marketing application approved under [PHS Act § 351(a)] for the commercial marketing of such biological product.”  Affiliation includes “any relationship of employment, control, or common ownership, whether direct or indirect, including through one or more intermediaries.”  A “qualified small business” is defined in the bill to mean “any entity with fewer than 500 employees, including employees of affiliates, and which is not affiliated with the holder of the marketing application approved under [PHS Act § 351(a)] for the commercial marketing of such biological product.”

Any determination that an applicable patent is eligible for a PTE must be made by the PTO Director “solely on the basis of the representations contained in the application for the extension.”  And if the PTO Director determines that a patent is eligible for extension and that the application requirements have been complied with, then the PTO Director “shall issue to the applicant for the extension of the term of the patent a certificate of extension, under seal, for 5 years” (emphasis added).  The PTE certificate must be recorded in the official file of the patent and is considered as part of the original patent.  Interim PTEs of 1-year in length may be granted if the the term of an applicable patent for which an application has been submitted would expire before a PTE certificate is issued or denied.

Of particular interest to us is the “Effective Date” provision of the bill.  It says: “This section shall take effect on the date of the enactment of this Act and shall apply to any unexpired patent issued before, on, or after that effective date.”  That got us thinking . . . .  This bill certainly did not materialize out of thin air.  There’s a particular interest behind the bill (as there is with many pieces of legislation).  And while there may be several patents out there for approved Section 351(a) BLAs claiming a method of using an old product for a new use that might benefit if the Independent Innovator and Repurposing Act is enacted, we suspect the bill is intended to address a particular patent for a particular biological product.  While we’re not sure which patent, we think the product is BOTOX (onabotulinumtoxinA) Injection, which FDA approved under BLA No. 103000/S-5215 on October 15, 2010 “for a new indication for the prophylaxis of headaches in adults with chronic migraine.”